The use of remdesivir outside of clinical trials during the COVID-19 pandemic
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(2020) 13:61
COMMENTARY
Open Access
The use of remdesivir outside of clinical trials during the COVID-19 pandemic Vesa Halimi1, Armond Daci2, Nevenka Ridova3, Irina Panovska-Stavridis3, Milena Stevanovic4, Venko Filipce5, Aleksandar Dimovski1 and Aleksandra Grozdanova1*
Abstract With a scientific background from filoviruses, paramyxoviruses, SARS-CoV, and MERS-CoV, remdesivir entered into the COVID-19 battle to become one of the favorable therapeutic candidates with potential antiviral activity in the treatment of this disease. Globally, remdesivir was accessed and investigated through clinical research (clinical trials) and clinical practice (compassionate use, expanded access, early access scheme, and emergency use). Currently, remdesivir approval status differs between states. This paper aims to review and analyze regulatory approaches for accessing and investigating remdesivir, by communicating regulatory variability between countries in terms of terminology, modalities, and protocols. Keywords: COVID-19, Remdesivir, Clinical practice, Clinical trials, Expanded access, Compassionate use, Early access scheme, Emergency use, Conditional approval
Introduction The undisputable medical need to find an effective therapeutic in the middle of COVID-19 pandemic, aligned regulatory authorities, clinicians, researchers, and manufacturers to consider using unapproved therapeutics or unapproved indications of already approved therapeutics with potential antiviral activity [1]. The main goal of finding an effective therapy is not only to determine the clinical efficacy and safety but also to determine the treatment duration, sensitive patients, and to ensure equitable patient access. As clinical trials began to show their preliminary outcomes, the established regulatory approaches to ensure the access to potential COVID-19 therapeutics have been reviewed, and as a consequence, some therapeutics have been revoked and are not recommended for use anymore [2, 3]. For instance, the rapid approval of emergency use of hydroxychloroquine and chloroquine in the USA on 28 * Correspondence: [email protected] 1 Faculty of Pharmacy, University Ss. Cyril and Methodius University, Skopje, North Macedonia Full list of author information is available at the end of the article
March 2020 [4], consequently revoked on 15 June 2020 [2], for safety and efficacy reasons, can be justified to some extent for the fact that these two antimalarial drugs had an already known safety profile in their approved indication(s). Also, the availability of scientific evidence in terms of safety and efficacy prompted FDA to decide that the potential benefits of hydroxychloroquine and chloroquine outweigh their potential risks, considering that no effective therapy was approved at that time [5]. On the other hand, several immunomodulating therapeutics like dexamethasone [6, 7], interleukin-1 inhibitors [8, 9], interleukin-6 inhibitors [10–12], interferon-beta [13], Bruton’s tyrosine kinase inhibitors [14], Janus kinase inhibitors [15], have raised h
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